Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT01401166
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed HER2-positive primary breast cancer
* No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)
* Completed neo-adjuvant chemotherapy prior to entry, if received
* At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
* History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years
* Inadequate bone marrow function
* Impaired liver function
* Inadequate renal function
* Serious cardiovascular disease
* Human immunodeficiency virus or hepatitis B or C infection
* Prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01401166
Study Brief:
Protocol Section:
NCT01401166